Anchoring Apparatus and Method for Attaching Device on Body

• US 20140378799A1
• Filed: 06/21/2013
• Published: 12/25/2014
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chattaraj, Sarnath, Dang, Kiem, Gulati, Poonam S., Shallenberger, James
• Granted Patent: US 10,194,864 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: B32B 2255/10 on synthetic resin layer or on natural or synthetic rubber layer
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 3/02 characterised by features of form at particular places, e.g. in edge regions non-uniform thickness B32B3/263
• CPC Class Codes: B32B 3/06 for securing layers together; for attaching the product to another member, e.g. to a support , or to another product, e.g. groove/tongue, interlocking
• CPC Class Codes: B32B 5/022 Non-woven fabric
• CPC Class Codes: B32B 5/06 characterised by a fibrous or filamentary layer mechanically connected, e.g. by needling to another layer, e.g. of fibres, of paper
• CPC Class Codes: B32B 5/26 another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: Y10T 428/24008 including fastener for attaching to external surface
• CPC Class Codes: Y10T 428/24017 Hook or barb

Abstract

The present invention describes improved systems and methods for attaching external medical devices to the body of a patient using a multilayer attachment apparatus. Medical devices that require attachment to the body, including monitoring devices, drug-infusing devices and the like, can utilize embodiments of the attachment apparatus and method described herein. Embodiments of the invention include new adhesive and hook and loop attachment mechanisms and methods for using embodiments of the multilayer attachment apparatus to attach medical device and/or medical device components to the body.

Claims

1. A multilayer attachment apparatus for anchoring a medical device to a body of a user comprising:

a nonwoven layer having a bottom surface and a top surface;

a first fastener material layer and a second fastener material layer, wherein each of the first and second fastener material layers have a bottom surface and a top surface, wherein at least a portion of the bottom surface of the first fastener material layer is connected to at least a portion of the top surface of the nonwoven layer, wherein at least a portion of the top surface of the first fastener layer and the bottom surface of the second fastener layer are removably connected to one another, and wherein the top surface of the second fastener material layer is connectable to at least a portion of the medical device.

2. The multilayer attachment apparatus of claim 1, wherein at least a portion of the bottom surface of the nonwoven layer includes an adhesive material.

3. The multilayer attachment apparatus of claim 1, further including:

an adhesive layer having a bottom surface and a top surface, wherein at least a portion of the bottom surface of the nonwoven layer is connected to the top surface of the adhesive layer.

4. The multilayer attachment apparatus of claim 1, wherein the first fastener material layer is a plurality of loop elements and the second fastener material layer is a plurality of hook elements.

5. The multilayer attachment apparatus of claim 1, wherein the first fastener material layer is a plurality of hook elements and the second fastener material layer is a plurality of loop elements.

6. The multilayer attachment apparatus of claim 1, wherein at least a portion of the top surface of the nonwoven layer is connectable to at least a portion of the medical device.

7. The multilayer attachment apparatus of claim 2, wherein the medical device includes a cannula;

and

wherein the nonwoven layer includes an aperture to receive the cannula.

8. The multilayer attachment apparatus of claim 3, wherein the medical device includes a cannula;

and

wherein each of the nonwoven layer and the adhesive layer include an aperture to receive the cannula.

9. The multilayer attachment apparatus of claim 1, wherein the nonwoven layer further includes a poly layer on at least a portion of the top surface of the nonwoven layer.

10. The multilayer attachment apparatus of claim 2, further including at least one removable liner to cover at least a portion of the bottom surface of the nonwoven layer to protect the adhesive prior to use.

11. The multilayer attachment apparatus of claim 3, further including at least one removable liner to cover at least a portion of the bottom surface of the adhesive layer to protect the adhesive prior to use.

12. The multilayer attachment apparatus of claim 10, wherein the at least one removable liner includes a tab.

13. The multilayer attachment apparatus of claim 1, wherein the nonwoven layer includes a first end and a second end;

wherein the top surface of the nonwoven layer at the first end is connectable to the medical device; and

wherein at least a portion of the bottom surface of the first fastener material is connected to the top surface of the nonwoven layer at the second end.

14. The multilayer attachment apparatus of claim 1, wherein the nonwoven layer includes a tab.

15. The multilayer attachment apparatus of claim 1, wherein the nonwoven layer includes an extended tab.

16. The multilayer attachment apparatus of claim 15, wherein the top surface of the nonwoven layer at the extended tab includes a fastening material to attach the extended tab to a surface of the medical device.

17. The multilayer attachment apparatus of claim 15, wherein the bottom surface of the nonwoven layer at the extended tab includes a poly layer.

18. The multilayer attachment apparatus of claim 1, wherein the first fastener material layer includes a first end and a second end, and wherein only the first end of the bottom surface of the first fastener material layer is connected to at least a portion of the top surface of the nonwoven layer.

19. The multilayer attachment apparatus of claim 1, wherein the first fastener material layer includes a tab.

20. The multilayer attachment apparatus of claim 1, wherein at least a portion of the bottom surface of the first fastener material include an adhesive material.

21. The multilayer attachment apparatus of claim 1, wherein the second fastener material layer includes a tab.

22. The multilayer attachment apparatus of claim 1, wherein at least a portion of the top surface of the second fastener material layer include an adhesive material.

23. The multilayer attachment apparatus of claim 1, wherein the medical device includes a first component and a second component.

24. The multilayer attachment apparatus of claim 23, wherein at least a portion of the top surface of the nonwoven layer is connectable to the first component of the medical device;

and

wherein at least a portion of the top surface of the second fastener material layer is connectable to the second component of the medical device.

25. The multilayer attachment apparatus of claim 23, wherein the medical device is a glucose monitoring device;

wherein the first component is a sensor base;

and wherein a second component is a sensor transmitter.

26. A system for improved glucose sensor monitoring device performance and accuracy comprising:

a glucose monitoring device including a sensor transmitter and a sensor base having a cannula and glucose sensor;

an attachment apparatus to attach the glucose monitoring device to a body of a user, the attachment apparatus including;

a nonwoven layer having a first end, a second end, a bottom surface and a top surface, wherein the bottom surface of the nonwoven layer including an adhesive to attach the nonwoven layer to the body, and wherein top surface of the first end of the nonwoven layer is connected to the sensor base and the first end of the nonwoven layer includes an aperture to receive the cannula;

a first fastener material layer and a second fastener material layer, wherein each of the first and second fastener material layers have a bottom surface and a top surface, wherein at least a portion of the bottom surface of the first fastener material layer is connected to at least a portion of the top surface of the second end of the nonwoven layer, wherein at least a portion of the top surface of the first fastener layer and the bottom surface of the second fastener layer are removably connected to one another, and wherein the top surface of the second fastener material layer is connected to the sensor transmitter.

27. The system of claim 26, wherein the first fastener material layer includes a first end and a second end, and wherein only the first end of the bottom surface of the first fastener material layer is connected to at least a portion of the top surface of the nonwoven layer.

28. A method for anchoring a medical device having a first component and a second component to a body of a user comprising the steps of:

providing a nonwoven layer having a first end, a second end, a top surface and a bottom surface, wherein at least a portion of the bottom surface includes an adhesive material, wherein at least a portion of the top surface at the first end of the nonwoven layer includes an adhesive material to attach to the first component of the medical device and at least a portion of the top surface at the second end of the nonwoven layer is connected to a first fastener material layer having a top surface, wherein the top surface of the first fastener material layer includes a plurality of loop elements;

providing a second fastener material layer having a top surface and a bottom surface, wherein the bottom surface of the second fastener material layer includes a plurality of hook elements and wherein at least a portion of the top surface of the second fastener material layer includes an adhesive material;

attaching the first component of the medical device to at least a portion of the top surface at the second end of the nonwoven layer;

attaching at least a portion of the top surface of the second fastener material layer to the second component of the medical device;

attaching the bottom surface of the nonwoven layer to the body of the user; and

attaching the bottom surface of the second fastener material layer to the top surface of the first fastener material layer.